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CTRI Number  CTRI/2023/05/052699 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 12/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare vasodilatory effect of desflurane vs sevoflurane using perfusion index as a measure  
Scientific Title of Study   A comparative study to evaluate vasodilatory effect of Desflurane vs Sevoflurane using Perfusion Index 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neeru Luthra 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India

Ludhiana
PUNJAB
141001
India 
Phone  9815500960  
Fax    
Email  drneeru1977@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gunjan Dhawan 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India

Ludhiana
PUNJAB
141001
India 
Phone  7009151875  
Fax    
Email  gunjandhawan024@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gunjan Dhawan 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India

Ludhiana
PUNJAB
141001
India 
Phone  7009151875  
Fax    
Email  gunjandhawan024@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeru Luthra  Dayanand Medical College and Hospital  Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001
Ludhiana
PUNJAB 
9815500960

drneeru1977@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Research and Ethical committee,Dayanand Medical College and Hospital  Approved 
Research and ethics committee,Dyanand medical college and hospital,Ludhiana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sevoflurane   Group S will be given anaesthesia using Sevoflurane through inhalational route at one MAC for 20 minutes 
Intervention  comparative study to evaluate Vasodilatory effect of Desflurane vs Sevoflurane using Perfusion Index   Anaesthesia will be induced using either Desflurane or Sevoflurane depending on Group allocation. 
Comparator Agent  Desflurane   Group D will be given desflurane through inhalational route at one MAC for 20 minute before incision  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  sixty adults of either sex, age group (18yr-65yr) belonging to the American Society of Anaesthesiologist (ASA) Physical status I and II adults scheduled for elective surgery under GA 
 
ExclusionCriteria 
Details  1.Receiving any medications that may affect vascular tone (eg vasoactive drugs, such as calcium channel blockers or angiotensin receptor blockers)
2.Cardiovascular or peripheral vascular disease (e.g. Diabetic vasculopathy or Raynaud’s disease)
3.Medications that may affect sympathetic or parasympathetic tone(e.g. beta blockers or anticholinergics)
4.Diabetes mellitus
5.Any neurological or psychiatric diseases, including history of, or treatment for, substance abuse, anxiety, or depression.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Perfusion index will be the primary outcome for the study.  Baseline Perfusion index will be noted and then continuously recorded every minute for 20 min ,after induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To compare heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.

 
Baseline HR, PI, SBP, DBP and MAP will be noted and then continuously recorded every minute for 20 min ,after induction of anaesthesia.

 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Sevoflurane and Desflurane are the most commonly used inhalational anaesthetics. These anaesthetics volatile cause dose-dependent effect on cardiovascular function, either through effects on the myocardium itself or by decreasing systemic vascular resistance (SVR) and sympathetic outflow. Perfusion index (PI) can effectively assess peripheral perfusion dynamics and vascular tone. It can be non-invasively and continuously obtained using pulse oximeter. With this background this study has been designed to compare the vasodilatory properties of Desflurane and Sevoflurane.A prospective randomized study will be conducted on 60 patients posted for surgery under general anaesthesia divided into two equal groups. Sevoflurane or Desflurane at 1.0 MAC will be used to maintain anaesthesia as per group allocation. PI will be recorded and compared in both the groups.Clinically, changes in heart rate and blood pressure are most important because, in patients at an increased risk of cardiovascular complications, both hypotension and tachycardia may cause a dramatic increase in the incidence of perioperative adverse events. PI is a novel predictor of changes in peripheral vasomotor tone. Hence, this study will help compare the two inhalational agents and find better agent with minimal perioperative adverse events due to tachycardia and hypotensionClinically, changes in heart rate and blood pressure are most important because, in patients at an increased risk of cardiovascular complications, both hypotension and tachycardia may cause a dramatic increase in the incidence of perioperative adverse events. PI is a novel predictor of changes in peripheral vasomotor tone. Hence, this study will help compare the two inhalational agents and find better agent with minimal perioperative adverse events due to tachycardia and hypotension.

 

 

 
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